- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05304962
First-in-Human Study of RGT-419B Alone and With Endocrine Therapy in Subjects With HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer
First-in-Human, Escalating Oral Dose Study of RGT-419B Given Alone and With Endocrine Therapy in Subjects With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Regor Central Office
- Phone Number: 617-315-9070
- Email: rgt-419b_01-101@regor.com
Study Locations
-
-
Florida
-
Port Saint Lucie, Florida, United States, 34952
- Recruiting
- Hem-Onc Associates of the Treasure Coast
-
Contact:
- Heather Yeckes-Rodin, MD
- Phone Number: 772-335-5666
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female >/= 18 years old
- ECOG Performance Status 0 to 1
- HR+, HER2- tumor by most recent biopsy with measurable disease
- Have had no more than 1 prior line of cytotoxic chemotherapy in the ABC setting AND no serious/severe toxicity to a prior CKD4/6i AND no known contraindication to receiving RT-419B AND have had all acute/residual toxic effects of any prior therapy
- In the ABC setting, eligible subjects must have failed to respond to or progressed after <3 lines of prior CDK4/6i therapy and unlimited lines of prior HT and have had no more than 1 prior line of chemotherapy. Eligible subjects must have received and progressed on any combination of HTs including any approved AI, SERD, or SERM, and/or any approved CDK4/6i in any order.
(5a) For subjects in Arm B, at least one line of prior therapy must have included a locally approved HT which was well tolerated and which the subject is willing to receive again (5b) Subjects with tumors harboring a PIK3CA mutation will be allowed to enroll, and treatment with a PI3Ki in combination with HT will be allowed as a prior line of therapy. Surgical excision of tumor tissue accompanied by chemotherapy or targeted therapy is also counted as 1 line of prior treatment.
Exclusion Criteria:
- Presence of visceral metastases with severe organ dysfunction as evidence by signs and symptoms, laboratory studies, lymphangitic spread and/or rapid progression of disease
- Pregnant or planning to become pregnant
- Prior irradiation to >25% of the bone marrow and/or inadequate bone marrow function or evidence of clinically significant end-organ damage
- Major surgery, chemotherapy, targeted therapy, experimental agents, or radiation within 14 days prior to Cycle 1, Day 1
- Active, serious medical condition that is not well controlled with locally approved medications allowed by the protocol
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
RGT-419B given alone as monotherapy
|
oral capsules
|
Experimental: Arm B
RGT-419B in combination with Hormonal Therapy
|
RGT-419B in combination with hormonal therapy (Selective Estrogen Receptor Degrader, Selective Estrogen Receptor Modulator, or Aromatase Inhibitor)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level in singlet and doublet therapy
Time Frame: 4 weeks (1 cycle)
|
Number of subjects who have a confirmed DLT at each cohort dose level in singlet and doublet study arms during the first 28-day cycle of RGT-419B treatment.
|
4 weeks (1 cycle)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety & Tolerability - Incidence, Severity, and Causality of all Treatment Emergent Adverse Events (TEAEs)
Time Frame: through study completion, an average of 1 year
|
Incidence, severity, and causality of all TEAEs will be assessed for all patient participating from Day 1 dosing through end of study.
|
through study completion, an average of 1 year
|
Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Cmax
Time Frame: through study completion, an average of 1 year
|
Plasma and urine samples that are being collected for PK assessment may also be used for exploratory metabolite identification
|
through study completion, an average of 1 year
|
Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Area Under Concentration-Time Curve (AUC0-t)
Time Frame: through study completion, an average of 1 year
|
Plasma and urine samples that are being collected for PK assessment may also be used for exploratory metabolite identification
|
through study completion, an average of 1 year
|
Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Area Under Concentration-Time Curve to Infinity (AUC0-inf)
Time Frame: through study completion, an average of 1 year
|
Plasma and urine samples that are being collected for PK assessment may also be used for exploratory metabolite identification
|
through study completion, an average of 1 year
|
Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Plasma Decay Half-Life (t 1/2)
Time Frame: through study completion, an average of 1 year
|
Plasma and urine samples that are being collected for PK assessment may also be used for exploratory metabolite identification
|
through study completion, an average of 1 year
|
Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: through study completion, an average of 1 year
|
Plasma and urine samples that are being collected for PK assessment may also be used for exploratory metabolite identification
|
through study completion, an average of 1 year
|
Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Accumulation rate after multiple doses
Time Frame: through study completion, an average of 1 year
|
Plasma and urine samples that are being collected for PK assessment may also be used for exploratory metabolite identification
|
through study completion, an average of 1 year
|
Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Cumulative urinary excretion
Time Frame: through study completion, an average of 1 year
|
Plasma and urine samples that are being collected for PK assessment may also be used for exploratory metabolite identification
|
through study completion, an average of 1 year
|
Tumor Response assessed by Investigator according to RECIST v1.1
Time Frame: through study completion, an average of 1 year
|
Tumor response measured by radiologic imaging techniques at baseline and throughout the study
|
through study completion, an average of 1 year
|
QTc Interval - Changes in corrected QT interval
Time Frame: through study completion, an average of 1 year
|
Number of subjects with a clinically significant increase from baseline in corrected QT (QTc) interval on repeated ECGs during RGT-419B monotherapy.
|
through study completion, an average of 1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom Burden
Time Frame: through study completion, an average of 1 year
|
Change from baseline in symptom burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) from baseline to end of treatment
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RGT-419B_01-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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